Acteon x-mind ac User manual

OPERATOR’S MANUAL
OPERATOR’S MANUAL • X-Mind AC • (06) • 05/2018• NXACEN010F
CMJN : 15/0/0/85 Pantone 432C RAL 7024 (Graphite grey)
CMJN : 80/0/10/0 Pantone 306C RAL 220 80 25

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MANUFACTURER
de Götzen®S.r.l. - a company of ACTEON Group
Via Roma, 45
21057 OLGIATE OLONA (VA) – ITALY
Tel. [phone]
Fax [phone]
www.acteongroup.com
For information and technical assistance, contact the manufacturer
[email protected]

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THE RADIOGRAPHIC SYSTEM DESCRIBED IN THIS MANUAL REFERS BOTH TO THE WALL
INSTALLATION AND THE MOBILE VERSION.
“de Götzen® S.r.l. - ACTEON Group” RESERVES ITSELF THE RIGHT TO MODIFY THE PRODUCTION
AND THE MANUAL WITHOUT NOTICE.
IT IS PROHIBITED TO MODIFY, COPY, REPRODUCE, DISPLAY, SHARE, DISCLOSE AND PUBLISH
THIS MANUAL AND ALL OTHER DOCUMENTS REFERRING TO “x-mind ac” IN ANY FORM
WITHOUT PRIOR WRITTEN CONSENT BY de GÖTZEN® S.r.l. – ACTEON Group.
THE MANUAL MUST ALWAYS BE KEPT NEAR THE MEDICAL DEVICE FOR FUTURE REFERENCE.
de Götzen® S.r.l. – ACTEON Group SHALL NOT BE LIABLE FOR AN INCORRECT USE OF THE
INFORMATION CONTAINED IN THIS MANUAL.

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1. CONTENTS
CONTROL PANEL ........................................................................................................................5
PRELIMINARY INFORMATION ..................................................................................................6
1.1. PRELIMINARY INFORMATION..............................................................................................................................6
1.2. INFORMATION FOR THE OPERATOR...................................................................................................................6
1.3. QUALITY DETERMINANTS IN X-RAY INTRAORAL RADIOGRAPHY....................................................................7
1.4. WARRANTY CODITIONS........................................................................................................................................8
1.5. TRANSPORT CONDITIONS....................................................................................................................................8
1.6. SAFETY WARNINGS................................................................................................................................................8
RADIOGRAPHIC SYSTEM ..........................................................................................................13
2.1. RADIOGRAPHIC SYSTEM.....................................................................................................................................13
2.2. SYSTEM COMPONENTS.......................................................................................................................................14
2.3. IDENTIFICATION TAGS........................................................................................................................................15
CONFIGURATION......................................................................................................................18
3.1. CONFIGURATION.................................................................................................................................................18
INSTRUCTIONS FOR USE..........................................................................................................20
4.1. INSTRUCTIONS FOR USE ....................................................................................................................................20
EXPOSURE VALUES ...................................................................................................................26
5.1. CHART OF DEFAULT EXPOSURE VALUES...........................................................................................................26
PROGRAMMING DEFAULT EXPOSURE VALUES ......................................................................31
6.1. PROGRAMMING DEFAULT EXPOSURE VALUES................................................................................................31
6.2. RESTORING ORIGINAL VALUES .........................................................................................................................33
DIAGNOSTIC .............................................................................................................................34
7.1. DIAGNOSTIC ........................................................................................................................................................34
CHAPTER 8.................................................................................................................................35
8.1. ERROR MESSAGES ...............................................................................................................................................35
VERIFICATION OF THE EXPOSURE FACTORS ..........................................................................36
9.1. VERIFICATION OF THE EXPOSURE FACTORS....................................................................................................36
SUGGESTED MAINTENANCE ....................................................................................................38
10.1. SUGGESTED MAINTENANCE ............................................................................................................................38
10.2. CLEANING THE OUTER SURFACES...................................................................................................................38
REPAIR .......................................................................................................................................40
11.1. REPAIR ................................................................................................................................................................40
IN CASE OF A MALFUNCTION, SEND THE DEFECTIVE PART FOLLOWING SPECIFIC INSTRUCTIONS PROVIDED
BY THE TECHNICAL SUPPORT OR USING THE ORIGINAL PACKAGING TO:.........................................................40
11.2. DISPOSAL ...........................................................................................................................................................40
ANNEX 1 ....................................................................................................................................41
A1. TECHNICAL SPECIFICATIONS..............................................................................................................................41
ANNEX 2 ....................................................................................................................................45
A2. INTENDED ENVIRONMENT .................................................................................................................................45
ANNEX 3 ....................................................................................................................................46
A3. LIST OF INTERNATIONAL STANDARDS AND DIRECTIVES................................................................................46
ANNEX 4 ....................................................................................................................................47
A4. DOSIMETRIC INDICATIONS ................................................................................................................................47
ANNEX 5 ....................................................................................................................................48
A5. ELECTROMAGNETIC COMPATIBILITY ................................................................................................................48
ANNEX 6 ....................................................................................................................................52
A6. DRAWINGS AND DIMENSIONS...........................................................................................................................52
ANNEX 7 ....................................................................................................................................54
A7. INSTALLATION ELECTRICAL SCHEME ................................................................................................................54

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CONTROL PANEL
X-RAY OUPTUT
SIGNAL
PAUSE
INDICATOR
MALFUNCTION
INDICATOR
SAVE IN
MEMORY
BITE - WING
EXAM
MANDIBULARY
LOWER TEETH
DIGITAL X-RAY
CONVENTIONAL
X-RAY
OCCLUSAL
EXAM
DISPLAY
KEY TO INCREASE
EXPOSURE TIME
KEY TO DECREASE
EXPOSURE TIME
TUBEHEAD
SELECTION
RADIOGRAPHIC
DISTANCE INDICATOR
SELECTION OF
PATIENT TYPE
TUBEHEAD
TYPE INDICATOR
RADIOGRAPHIC
CURRENT INDICATOR
RADIOGRAPHIC
VOLTAGE INDICATOR
MAXILLARY
LOWER TEETH

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PRELIMINARY INFORMATION
1.1. PRELIMINARY INFORMATION
Before beginning to use the “x-mind ac” radiographic system, it is mandatory to carefully read and follow the
instructions contained herein, so as to obtain the best possible performance and to assure the safety of the
patient, operator, device and environment.
Always pay close attention to the
CAUTION
WARNING
PLEASE NOTE
messages when operating the system.
LEGEND
CAUTION
The word CAUTION identies those occurrences which might compromise the operator’s personal safety or cause injuries to people.
!
WARNING
The word WARNING identies those occurrences which might compromise the radiographic system’s performance.
PLEASE NOTE
PLEASE NOTE serve to give special indications so as to facilitate maintenance or make important information clearer.
1.2. INFORMATION FOR THE OPERATOR
Dear Customer,
thanks for having chosen the “x-mind ac” radiographic system.
It is designed and manufactured by de Götzen® S.r.l. – ACTEON Group and is the result of many years of experience
in the eld of radiology and in the application of advanced electronics.
This high performing system represents a further development of technological research at the service of dental
radiography.
The “x-mind ac” is an X-ray generator for dental intra-oral X-ray imaging, particularly, “x-mind ac” is an extra-
oral source of X-rays, intended to be used for producing diagnostic dental radiographs for treatment of disease
of
teeth, jaw and oral structures.
From a clinical point of view, “x-mind ac” can be applied in routine dental radiography examinations involving
the diagnosis, treatment, i.e. surgical or interventional, of disease of the teeth, jaw and oral cavity structures.
Its intended medical applications are:
• Generic dentistry
• Dental implantology
• Dental surgery
The intended population can be whatever, anyway the sustainability of the X-ray exposure must be evaluated
by surgeons, dentists and qualied and authorized physicians.
11

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The Intended user prole is an able-bodied specialized surgeon, dentist and authorized personnel, who meet
the requirements provided by the national laws in force in the country of installation; they must understand the
language of the country where the device is installed. The intended conditions of use are detailed in Annex A2
(“Intended Environment”).
PLEASE NOTE
This manual does not contain all the recommendations and the obligations relative to the possession of a source of ionising radiations – since
they do vary from Country to Country – but only the most common ones.
The user must consult his country’s legislation so as to full all local obligations.
!
WARNING
This manual describes how to set and use the “x-mind ac” X-ray system.
The operator must read and understand the manual before using the medical device.
This manual must be always kept as a reference document.
Before using this device for the rst time, it is essential to thoroughly and carefully read the instructions, CAUTION and WARNING messages
listed in the present chapter.
It is mandatory to comply with these instructions every time the device is used.
“x-mind ac” is compatible with all kind of X-ray detectors which have been designed and certied for dental intra-oral radiology; in detail,
such a compatibility is ensured by the compliance of the “x-mind ac” device with the basic safety and essential performance requirements
of the IEC 60601-2-65: 2012.
1.3. QUALITY DETERMINANTS IN X-RAY INTRAORAL RADIOGRAPHY
Image quality is linked to the precise and accurate acquisition of information from the X-ray beam transmitted
through the patient (i.e., the X-ray detector). Most problems in dental radiography are not the result of X-ray
equipment failure: the production of consistent and high quality X-ray diagnostic images, concurrent with
minimal patient exposure, depends generally on different components:
quality performance of equipment, characteristics of the modules used which affect the imaging system
resolution (i.e.: X-ray image detector type and relevant image processing chain, analogue or digital) and optimal
performance of the operator.
Among the physical factors for achieving optimum image quality, the following can be considered:
- optimum optical density and Wiener spectrum,
- detectors for radiography must meet the needs of the specic radiological procedure where they will be used
and key parameters are spatial resolution, uniformity of response, contrast sensitivity, dynamic range, acquisition
speed and frame rate
- minimization of motion blurring (using short exposure times),
- minimization of geometric blurring (reducing the focal spot size and/or of the object-lm distance),
- geometric distortions,
- correct positioning: errors in patient positioning when using uncoupled positioning devices during the various
typologies of X-ray examinations may lead to exposure errors, which require additional X-ray exposures, thereby
increasing the radiation dose adsorbed by the patient.
This means that it is absolutely essential and mandatory that the operator consider the performances not only
of the “x-mind ac” equipment itself, but the whole chain of components that bring to the nal X-ray diagnostic
image.
The essential parameters and relevant metrics which describe the performance of dental X-ray system, with
regard to imaging properties and patient dose, methods of testing and whether measured quantities related to
those parameters comply with the specied tolerances, are stated by the respective manufacturers and by the
requirements specied by the respective applicable standards.
Radiographic lms, lm processing, digital X-ray image detectors, and imaging plates are vital parts in the
imaging chain. It is responsibility of the operator to ensure that these components perform in an acceptable way,
with respect to sensitivity, contrast and absence of artifacts. A test of the performance of these components shall
precede any acceptance test measurement involving the irradiation of the X-ray detectors using the “x-mind ac”.

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!
WARNING
It is full responsibility of the operator and RESPONSIBLE ORGANIZATIONS of the “x-mind ac” to check that any kind of X-ray detectors used
with the “x-mind ac” are in compliance with the requirements stated by their specic regulations in force and to the specications stated
by their respective manufacturers.
1.4. WARRANTY CODITIONS
Inappropriate use or any arbitrary tampering with the equipment exempt de Götzen® S.r.l. – ACTEON Group,
as manufacturer of the “x-mind ac” radiographic system, from any service under warranty or from any other
liability.
The warranty is valid only if the following precautions are taken:
- any repairs, modications, adjustments, recalibrations must be performed only by de Götzen® S.r.l. – ACTEON
Group
- the installation must be made by professionally qualied technicians according to the regulations in force
- the system must be installed and used in compliance with the instructions given in this Manual and for the
purposes and applications for which it was designed
- the power supply must be adequate to supply the required power indicated in the radiographic system’s
nameplate data
- in order to safeguard one’s warranty rights, please ll in the enclosed Warranty Document, immediately after
the installation is completed, together with the technician
- The system must be checked completely at least each 12 months by professionally qualied technicians
according to the regulation in force. Use the manuals provided with the device “x-mind ac” for reference.
- In case of repair, please use only spare parts from the manufacturer of the “x-mind ac”.
Otherwise basic safety and essential performances of the device will not be guaranteed.
de Götzen® S.r.l. – ACTEON Group is not responsible for any damage caused by any person or thing as a
consequence of non-compliance of any of the guidelines contained in all the manuals provided with the
“x-mind ac” device.
CAUTION
No compliance of any of the above mentioned rules and all the indications provided by the manufacturer in the documentation, or successively
in written paper or electronic format, will result in losing the warranty of the product and the manufacturer will be discharged from any obliga-
tion, including consequential damages, direct or indirect that may derive to people, things or environment. Furthermore, the facility represen-
tative, customer or employees of the facility, will be liable for any damage and/or incident and/or degeneration of the health status of a patient,
operator, involved people and the surrounding environment.
1.5. TRANSPORT CONDITIONS
The “x-mind ac” radiographic system travels at the receiver’s own risk.
All claims for damage or miscarriage regarding the shipment must be pointed out in the
presence of the shipping agent.
In case of miscarriages, or actual or suspected damage, the receiver shall indicate the proper reserves on the
way-bill or on the consignment note.
1.6. SAFETY WARNINGS
A few safety recommendations which should be followed when using the “x-mind ac” radiographic system are
listed here below.

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CAUTION
GENERAL REQUIREMENTS
RESPONSIBLE ORGANIZATION is the authority that has the responsibility for the USE and MAINTENANCE of the “x-mind ac” radiographic system.
Training and preparation of personnel is responsibility of THE RESPONSIBLE ORGANIZATION.
“x-mind ac” radiographic system is an X-ray generator and must be used and handled only by specialised surgeons, dentists and authorized
personnel, who meet the requirements provided by the national laws in force in the country of installation.
It is mandatory for the RESPONSIBLE ORGANIZATION to provide a routine and special maintenance schedule for medical equipment; this
schedule must be documented for every device and transmitted to the various operating levels (*). The preventive maintenance (that must be
performed at least every 12 months), which includes functional, performance and safety tests of the device, must be carried out by qualied,
authorized professional technicians. It is mandatory to ensure patients’ health and safety and proper “x-mind ac” radiographic system operation
(IEC 60601-1 etc.). These operations must be carried out according to the methods and frequency indicated in this manual and in the installation
and maintenance manual. Failure to comply with this requirement or with the messages concerning anomalies will release the manufacturer
from any liability for direct and indirect injuries to persons and/or damage to property or the environment. Furthermore, the managers of the
facility, customers or collaborators will be held liable for any damage and/or accidents and/or degeneration of patients’ or operators’ health or
of the surrounding environment.
The RESPONSIBLE ORGANIZATION must also provide for the safe and proper use of the equipment.
(*) For Italy refer to Presidential Decree 14/01/1997, Legislative Decree No. 81/2008 (as subsequently amended and modied).
Operators must know the environmental and operating specications of the device, as well as the procedures to follow in the event of hazards or
emergency stops.
“x-mind ac” radiographic system has been designed to acquire radiography images for dental intraoral X-ray imaging. The “x-mind ac” medical
device must not be used for X-ray imaging of other body parts.
Carefully follow the instructions of this manual to install, operate and maintain the “x-mind ac” radiographic system. In the event that local laws
and standards are more restrictive than the manufacturer’s indications, the former supersede the latter.
The RESPONSIBLE ORGANIZATION must comply with the standards and regulations in force concerning the installation of the medical device in
consideration of the place of installation.
The operator is cautioned to monitor the patient and the parameters of the “x-mind ac” radiographic system throughout the entire duration of
the X-ray examination.
It is prohibited to modify any part of the “x-mind ac”medical device.
de Götzen S.r.l. – ACTEON Group and its authorized technicians are not required to verify compliance of the installation site with local standards
concerning electrical safety and X-ray protection and with any other directive concerning safety in force in the country of installation.
The RESPONSIBLE ORGANIZATIONS of the facility must ensure compliance of the installation site with the local laws in force.
Before each examination, it is mandatory to apply to the collimator cone (Beam Limiting Device) a disposable protection sheath designed to
cover the end part of the X-ray unit, which is more susceptible of being directly contaminated during the X-ray exposure (class I Medical Device
Directive 93/42/EEC and subsequent amendments). It can come into contact with the patient’s skin: verify biocompatibility according to the
principles given in the ISO 10993 series of standards, refer for details to the disposable use protection’s instructions for use.
Before operating the “x-mind ac” radiographic system you must assure that the device has no visible signs of damage.

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CAUTION
PROTECTION AGAINST RADIATIONS
“The general principles regarding safety and protection of workers and people” must always be applied when using the unit:
1. Justication of the practice
2. Protection Optimisation
3. Reduction of the limits of individual dose and risks
The “x-mind ac” is a medical device that generates X-rays; therefore, both the patients and the operator are exposed to risks due to ionizing
radiation. The physician must assess the actual need for X-ray exposure.
All personnel present during an X-ray examination must comply with safety regulations concerning protection against radiation. For their own
safety, the operator must always keep a distance of more than 2 meters (6 ft.) and out of the path of the X-ray beam, in order to avoid the exposi-
tion to the stray radiation.
The “x-mind ac” medical device must be used in compliance with the local standards in force and with the international directives concerning
radiation protection.
The device must comply with the guidelines and indications provided by an accredited specialist in radiation protection, who will recommend, if
necessary, additional shields or precautions for every specic case.
The device installation site must be shielded in compliance with the local standards in force to protect the operator, patient and other people
against X-rays.
The “x-mind ac” device is intended to be used solely by surgeons, dentists and qualied and authorized physicians. The operator must:
- determine, when appropriate, the possible need for sedation and the related operating methods and appropriate precautions for the patient
- supervise the entire X-ray examination procedure, paying attention to the indications and information from the unit.
The device must be used only for diagnostic purposes by qualied and authorized dentists and/or physicians.
The operator and other personnel must keep clear from the patient during the scan.
The personnel involved in the radiographic examination must take all the safety measures concerning radiation protection.
It is the operator’s responsibility to protect the patient against unnecessary or excessive radiation doses.
Additional protection devices (aprons, collars, etc) are required to protect the patient from radiation.
Before exposing patients with pacemakers, contact the manufacturer of the latter to ensure that the X-rays generated by “x-mind ac” do not
interfere with its functionality.
“x-mind ac” generates X-rays: before using this X-ray system please refer to the regulation in force in your area concerning paediatric patients,
pregnant women and anyone with health issues that contraindicate the use of X-rays. Investigate and make sure of this condition before starting
the exposure.
This symbol indicates X-ray hazard.

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CAUTION
MECHANICAL RISK
Before removing the tubehead from the positioning arm, RELEASE THE SPRING.
The sudden opening of the joint may cause damage to people and/or things.
Check that the installation of the unit complies with the mechanical specications of the support (walls, ceiling, etc..) where it is installed.
Adjustments or any kind of attempt of repairing or disassembling must only be performed by qualied and authorized service personnel.
The “x-mind ac” must not be used in environments or close to environments subjected to mechanical vibrations or mechanical shocks.
CAUTION
ELECTRIC SAFETY
The radiographic system contains high voltage. It is prohibited to inspect internal parts of the system.
Never attempt to open the X-ray tubehead.
The covers on the “x-mind ac” radiographic system must only be removed by qualied and authorized service personnel.
The unit must be used only in environments that are in compliance with all electrical safety standards set forth for medical environments.
To avoid the risk of electric shock, this device must only be connected to a supply mains with protective earth.
The unit is NOT equipped with protections against penetration of liquids; it will therefore be necessary to make sure that no water or other
liquids penetrate inside in order to avoid short circuits or corrosion.
Always disconnect the radiographic system from the power supply and wait for 2 minutes before beginning cleaning and disinfecting operations.
Do not connect the X-ray system to a multiple portable socket outlet (MPSO) nor to any type of extension cord.
External equipment intended for connection to signal input, signal output or other connectors shall comply with the relevant product standard
e.g. IEC 60950-1 for IT equipment and the IEC 60601-series for medical electrical equipment. In addition, all such combinations – systems – shall
comply with the safety requirements stated in the standard IEC 60601-1, edition 3, clause 16. Any equipment not complying with the leakage
current requirements in IEC 60601-1 shall be kept outside the patient environment i.e. at least 1.5 m from the patient support.
It is mandatory to use an isolation device (Separation Device) to isolate the equipment located outside the patient environment from the equip-
ment located inside the patient environment. In particular such a Separation Device is required when a network or data connection is made.
The requirements on the Separation Device is dened in IEC 60601-1, edition 3, clause 16.
For the wall version of “x-mind ac”:
based on the IEC 60601-1, the installation is a permanent type (xed). IT IS NOT ALLOWED TO connect the equipment to the main supply using a
plug.
The cone (beam limiting device) is an APPLIED PART of the system and it is classied as type B.

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CAUTION
EMC COMPATIBILITY
EMC requirements must be considered and the “x-mind ac” must be installed and used accordingly with the specic EMC information provided in
the accompanying documents.
The device complies with the EMC (Electromagnetic Compatibility) requirements, according to IEC 60601- 1-2. Radio transmitting equipment,
cellular phones etc. shall not be used in close proximity of the unit as they could inuence the performance of the system.
Carefully read the indications relevant to the EMC in the dedicated appendix A5. EMC compatibility of this manual.
CAUTION
PROTECTION AGAINST EXPLOSIONS
The radiographic system MUST NOT be used in the presence of disinfectant, ammable or potentially explosive gases or vapours that might
catch re and cause damage.
In case these disinfectants have to be used, let the vapour completely disperse before turning on the radiographic system.
CAUTION
SYSTEM MODIFICATIONS OR UPGRADES
Modications or upgrades of the system can be carried out only if advised by de Götzen® S.r.l. – ACTEON Group and performed by authorized
and qualied personnel, using ONLY genuine original spare parts of de Götzen® S.r.l. – ACTEON Group.
de Götzen® S.r.l. – ACTEON Group proscribes improper, unauthorized modications or upgrades of the device, in order to avoid malfunctions
resulting in breakdowns and/or accident for patient, operator and equipment. de Götzen® S.r.l. – ACTEON Group assumes no responsibility and,
consequently, declines all responsibility with respect to direct or indirect damages to people, the device or environment due to these reasons.
Do not remove or attempt to remove the plastic covers of the device.
It is strictly forbidden to attempt to repair electronic or mechanical parts by yourself.
Disregarding this warning can result in irreversibly compromising the overall safety of the system and can be dangerous for operators, patients
and environment.

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RADIOGRAPHIC SYSTEM
2.1. RADIOGRAPHIC SYSTEM
The “x-mind ac” radiographic system guarantees the maximum safety both for the operator and the patient.
It is built in compliance with the following European Directives:
►93/42/EEC and subsequent amendments MEDICAL DEVICES
►EURATOM 96/29 IONISING RADIATIONS
The following protective measures were adopted in the design and construction of the unit:
- protection against the risk of electric injuries, ensured by a grounded protection conductor;
- protection against leakage radiation, made negligible by the shielded casing;
- protection against excessive radiations, thanks to the immediate activation of the safety device;
- protection against continuous service, since the system is designed, according to standards, not to allow use in
radioscopy;
- protection for the patient against dangerous radiations, obtained by means of the high
frequency technology capable of producing a constant and hard radiation;
- protection against exposure mistakes obtained with the high frequency technology which is unaffected by
voltage uctuation and consequently capable to guarantee extremely accurate exposure parameters;
- protection for the operator against irradiation ensured by the extensible cable of the hand control which allows
for a safety distance of more than 2 meters (6 ft.);
- protection against involuntarily selection of radiographic technique (FILM or DIGIT) obtained, according to
standards, by means of conrmation on the selection key.
“ELECTRO-MEDICAL” CLASSIFICATION
According to paragraph §6 of the general safety regulations CEI EN 60601-1: 2007 on safety of medical equipment,
the system is classied as: Class I - Type B
“MEDICAL DEVICES” CLASSIFICATION
According to the classication rules indicated in attachment IX of the EEC Directive 93/42 on medical devices and
subsequent amendments the system is classied as: Class IIb
“E.M.C.” CLASSIFICATION
According to paragraph §4 of the CEI EN 55011, the system is classied as: Group 1 – Class B
22

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2.2. SYSTEM COMPONENTS
“x-mind ac” radiographic system (Fig. 1) consists of:
1. x-mind ac TIMER
The timer is the control panel used to manage the exposure times and to safely use the tubehead.
To make the exposure, the control button with safety key is available.
The timer can be connected to n° 2 ac tubeheads.
In case of alternate current tubeheads the technology of the timer is “self - compensating”:
depending on the line voltage uctuation, the microprocessor automatically modies the predetermined
exposure time ensuring a constant dose to the patient.
This technological expedient avoids the repetition of the exposure because of over/under exposure errors.
2. BRACKET
The horizontal bracket is available in 3 different lengths (110 cm, 80 cm, 40 cm) and represents the support for
the pantograph arm. Its shaft is xed in a dedicated section of the timer (top or bottom) and allows for 180°
movement.
3. PANTOGRAPH ARM
Thanks to the new shape and new mechanisms of the positioning arm, it can be adjusted in height and depth in
order to precisely explore any spot in its reach.
It is made of light alloy with an ABS coating.
4. x-mind ac TUBEHEAD
The intra-oral tubehead “x-mind ac” is a monoblock type and its light alloy housing contains an airtight
compartment.
The high voltage transformer, the X-ray tube and the expansion chamber are submerged in highly dielectric
insulating oil inside a light alloy container.
The expansion chamber guarantees an adequate compensation to oil expansion for the entire temperature
range.
The X-ray tube is located in the back part of the container, allowing a source-skin distance 50% higher than
traditional structures.
Fig. 1

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5. CONE
The collimator cone or Beam Limiting Device represents the applied part of the device. Made of transparent
polycarbonate, or alternatively of lead-coated polycarbonate, it ensures:
- the correct distance between focal spot and skin
- dimension, direction and centering of X-ray beam
- the realization of different radiographic technique (biting and parallel technique).
During X-ray exposition, the collimator cone comes in contact with the skin of the patient.
Before each exam, it is necessary to apply to the cone a disposable protective cover designed to cover the end
part of the X-ray generator.
Such protection is useful to avoid crosscontamination (from patient to patient).
2.2.1. OPTIONAL ACCESSORIES
►SECOND CONTROL BUTTON
►x-mind ac LIGHT
(Rx signalling lamp for external use)
►x-mind ac ECB
(remote control button)
2.3. IDENTIFICATION TAGS
The identication tags on the tubehead, on the timer and on the cone indicate the model number, the serial
number, the manufacturing date and the main technical characteristics.
2.3.1. TUBEHEAD
Model 230 V
Model 220 V
Model 115 V
Model: x-mind ac
®
de Götzen S.r.l.
®
Via Roma 45 - 21057 Olgiate Olona (VA) - ITALY
70kVp 8mA
230V ~ 50/60Hz
TOSHIBA DG-073B-AC
Rated line voltage:
X-ray tube:
Total filtratio n: 2,3mm Al / 70kV 0.7mm
Class I
tub e:
SN SN
0477
Model: x-mind ac
®
de Götzen S.r.l.
®
Via Roma 45 - 21057 Olgiate Olona (VA) - ITALY
70kVp 8mA
220V ~ 50/60Hz
TOSHIBA DG-073B-AC
Rated line voltage:
X-ray tube:
Total filtratio n: 2,3mm Al / 70kV 0.7mm
Class I
tub e:
SN SN
0477

Page 16 of 55
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2.3.2. TIMER
Model 230 V
Model 220 V
Model 115 V
CONE
GRADUATED SCALE
Model: x-mind ac
®
de Götzen S.r.l.
®
Via Roma 45 - 21057 Olgiate Olona (VA) - ITALY
70kVp 8mA
115V ~ 50/60Hz
TOSHIBA DG-073B-AC
Rated line voltage:
X-ray tube:
Total filtratio n: 2,3mm Al / 70kV 0.7mm
Class I
tub e:
SN SN
0477
Model: x-mind ac
®
de Götzen S.r.l.
®
Via Roma 45 - 21057 Olgiate Olona (VA) – ITALY
Rated line voltage:
Absorbed power:
230V 50/60Hz Class I
0,8kVA IP20
~
SN
0477
Model: x-mind ac
®
de Götzen S.r.l.
®
Via Roma 45 - 21057 Olgiate Olona (VA) – ITALY
Rated line voltage:
Absorbed power:
220V 50/60Hz Class I
0,79kVA IP20
~
SN
0477
Model: x-mind ac
®
de Götzen S.r.l.
®
Via Roma 45 - 21057 Olgiate Olona (VA) – ITALY
Rated line voltage:
Absorbed power:
115V 50/60Hz Class I
0,66kVA IP20
~
SN
0477

Page 17 of 55
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OPERATOR’S MANUAL • X-Mind AC • (06) • 05/2018• NXACEN010F
PICTOGRAMS USED
SYMBOL INDICATING THE MANUFACTURER
THIS SYMBOL GUARANTEES THAT THE RADIOGRAPHIC SYSTEM COMPLIES WITH THE
REGULATIONS CONTAINED IN THE EUROPEAN DIRECTIVE EEC 93/42 REGARDING MEDICAL
DEVICES
SIZE OF THE FOCAL SPOT
THE DEGREE OF PROTECTION AGAINST DIRECT AND INDIRECT ELECTRIC CONTACTS IS B
TYPE
SYMBOL INDICATING THE SERIAL NUMBER
SYMBOL INDICATING DANGER DUE TO IONISING RADIATIONS
X-ray EMISSION (IEC 60417)
PAUSE (IEC 60417)
ATTENTION, REFER TO THE ATTACHED DOCUMENTS
INSTRUCTIONS IN ELECTRONIC FORMAT
REFER TO MANUAL’S INSTRUCTIONS
WEEE (Waste Electrical and Electronic Equipment) SYMBOL, IN CONFORMITY WITH 2012/19/
CE DIRECTIVE AND EN 50419 STANDARD.

Page 18 of 55
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CONFIGURATION
3.1. CONFIGURATION
The “x-mind ac” radiographic system is provided in the “standard mode” conguration.
On the control panel the LED relevant to the following exposure parameters will light up:
No. of the selected tubehead
LED 1
supplied cone
LED 8” = SHORT CONE
LED 12” = LONG CONE
Type of tubehead
LED AC = ALTERNATE CURRENT
radiographic voltage
LED 70kV
radiographic current
LED 8mA
type of patient
LED ADULT
radiographic technique
CONVENTIONAL LED D
The following exposure times (s) have been stored:
0,080 – 0,100 –0,125 – 0,160 – 0,200 – 0,250 – 0,320 – 0,400 – 0,500 – 0,630 – 0,800 – 1,00 – 1,250 – 1,600 – 2,000
– 2,500 – 3,200
PLEASE NOTE
These times are in compliance with current CEI EN 60601-1: 2007 standard and with the ISO 497 series R’10 recommendations.
THEY CANNOT BE MODIFIED
33

Page 19 of 55
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OPERATOR’S MANUAL • X-Mind AC • (06) • 05/2018• NXACEN010F
Certain exposure values which depend on the selection of the operating parameters have been predened:
►cone (8”/12”)
►type of patient (ADULT/CHILD)
►radiographic tecnique
►intra-oral test
PLEASE NOTE
These values have to be considered as “recommended”: it is possible to change these values if necessary. (refer to Charter 5 and 6)
To modify these exposure values
►Type of patient (ADULT/CHILD)
►Radiographic technique
(refer to Chapter 4)
To modify these exposure values
►N° of tubehead (1/2)
►Type of tubehead (AC/DC)
►N° control button
►Type of cone (8” /12”)
change the dip-switch position, inside the timer
THIS OPERATION MUST BE CARRIED OUT BY THE INSTALLER ONLY

Page 20 of 55
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INSTRUCTIONS FOR USE
4.1. INSTRUCTIONS FOR USE
1° - TURN ON
Bring the main switch located on the upper part of the timer to the “I” position (ON)
Bring the key switch to the “I” position (ON)
1. the green light turns on, indicating that the system is powered
2. the LEDs of the set parameters automatically light up
3. the exposure time is shown on the display
CAUTION
If an error is detected when the system is turned on, please refer to Chapter 8 ERROR MESSAGES of this Manual
PLEASE NOTE
The exposure time and parameters which appear on the display are the last that were set before the timer was turned off.
If the timer remains inactive for a few minutes, it switches to the stand-by mode.
Press any key on the control panel to restore it to the operative mode.
44